MARVELOUS- stannous fluoride paste 
Batool Pharma International, Inc.

----------

Marvelous toothpaste

Drug facts

Active Ingredients:

Stannous Fluoride 0.454 % (0.14% w/v fluoride ion)

Purpose

Anticavity, antigingivitis Anti sensitivity toothpaste

Uses:

Aid in the preventing of dental cavities 

Warnings

Keep out of reach of children

under 12 yrs. Of age. If swallowed, get medical help or contact a poison control center right away. 

Ask dentist or physician 

before use, if you have allergy or have allergic reaction to medications or ingredients in this product.

Directions

Adult and children 12 yrs. of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or directed by a dentist or physician.

-ASK A DENTIST

Other information

Products containing stannous fluoride may produce surface staining of the teeth

Other ingredients:

Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Carrageenan, Sodium Gluconate, Xanthan Gum, Zinc, Citrate, Stannous Chloride, Sodium Saccharin, Sodium Hydroxide, Sucralose, Titanium Dioxide, Tea Tree Oil (Melaleuca Alternafolia: Antibacterial, Anti Vital, Anti Fungus, Antiseptic)

Question(s):

Email us at batoolpharma@gmail.com

Package Labeling:

Label

MARVELOUS 
stannous fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69179-000
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ZINC (UNII: J41CSQ7QDS)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69179-000-011 in 1 CARTON08/01/2022
1116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02108/01/2022
Labeler - Batool Pharma International, Inc. (079242646)

Revised: 11/2023
Document Id: 09ceda1d-1293-bf08-e063-6394a90a0795
Set id: 02a3d1a8-1c0b-4cd6-9ba9-64a9233f0faf
Version: 3
Effective Time: 20231110
 
Batool Pharma International, Inc.